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A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.一项评估阿立哌唑 2 个月长效注射剂用于精神分裂症或双相 I 型障碍成人的安全性、耐受性和药代动力学的随机、开放标签、多剂量、平行臂、关键性研究。
CNS Drugs. 2023 Apr;37(4):337-350. doi: 10.1007/s40263-023-00996-8. Epub 2023 Mar 24.
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The Economic Burden of Schizophrenia in the United States.美国精神分裂症的经济负担。
J Clin Psychiatry. 2022 Oct 10;83(6):22m14458. doi: 10.4088/JCP.22m14458.
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Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.全球、区域和国家 204 个地区 1990-2019 年 12 种精神障碍疾病的负担:基于 2019 年全球疾病负担研究的系统分析。
Lancet Psychiatry. 2022 Feb;9(2):137-150. doi: 10.1016/S2215-0366(21)00395-3. Epub 2022 Jan 10.
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Real-World Evidence of the Clinical and Economic Impact of Long-Acting Injectable Versus Oral Antipsychotics Among Patients with Schizophrenia in the United States: A Systematic Review and Meta-Analysis.美国精神分裂症患者长效注射抗精神病药与口服抗精神病药的临床和经济影响的真实世界证据:系统评价和荟萃分析。
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Time to Treatment Discontinuation in German Patients with Schizophrenia: Long-Acting Injectables versus Oral Antipsychotics.德国精神分裂症患者停药时间:长效注射剂与口服抗精神病药。
Clin Drug Investig. 2021 Jan;41(1):99-113. doi: 10.1007/s40261-020-00990-8. Epub 2020 Dec 17.
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Early initiation of long-acting injectable antipsychotic treatment is associated with lower hospitalization rates and healthcare costs in patients with schizophrenia: real-world evidence from US claims data.长效注射抗精神病药物治疗的早期启动与精神分裂症患者的住院率和医疗保健成本降低相关:来自美国索赔数据的真实世界证据。
Curr Med Res Opin. 2019 Jul;35(7):1231-1239. doi: 10.1080/03007995.2019.1571295. Epub 2019 Jan 31.
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Relapse prevention: a cost-effectiveness analysis of brexpiprazole treatment in adult patients with schizophrenia in the USA.复发预防:美国成年精神分裂症患者使用布瑞哌唑治疗的成本效益分析。
Clinicoecon Outcomes Res. 2018 Aug 16;10:443-456. doi: 10.2147/CEOR.S160252. eCollection 2018.
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Effectiveness of Long-Acting Injectable vs Oral Antipsychotics in Patients With Schizophrenia: A Meta-analysis of Prospective and Retrospective Cohort Studies.长效注射抗精神病药与口服抗精神病药治疗精神分裂症患者的疗效比较:前瞻性和回顾性队列研究的荟萃分析。
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9
Predictive factors of overall functioning improvement in patients with chronic schizophrenia and schizoaffective disorder treated with paliperidone palmitate and aripiprazole monohydrate.使用棕榈酸帕利哌酮和阿立哌唑一水合物治疗的慢性精神分裂症和分裂情感性障碍患者总体功能改善的预测因素。
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10
Budget impact analysis of long-acting injectable aripiprazole once-monthly 400 mg in bipolar I disorder in the USA.美国长效注射用阿立哌唑每月一次400mg治疗双相I型障碍的预算影响分析。
J Comp Eff Res. 2018 Jul;7(7):627-636. doi: 10.2217/cer-2018-0009. Epub 2018 Apr 25.

每两个月一次阿立哌唑长效注射剂对美国成年精神分裂症患者的预算影响。

Budget impact of aripiprazole once every 2 months long-acting injectable for adult patients with schizophrenia in the United States.

作者信息

Diaby Vakaramoko, Pandey Shubhram, Sanogo Vassiki, Dhayan Almutairi Reem, Kanoria Yagyesh, Nag Soma S

机构信息

Global Value and Real-World Evidence, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ.

Pharmacoevidence, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ.

出版信息

J Manag Care Spec Pharm. 2025 Jan;31(1):53-59. doi: 10.18553/jmcp.2025.31.1.53.

DOI:10.18553/jmcp.2025.31.1.53
PMID:39745838
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11695834/
Abstract

BACKGROUND

Schizophrenia is a chronic psychiatric disorder, affecting 1.1% of the adult population in 2020 in the United States. Antipsychotic treatment is commonly used in schizophrenia management to help reduce the likelihood of symptom recurrence and relapse. Aripiprazole once every month, a long-acting injectable antipsychotic formulation with an established efficacy and safety profile, is approved by the United States Food and Drug Administration as a maintenance treatment for schizophrenia. A new ready-to-use formulation of aripiprazole for administration once every 2 months (Ari 2MRTU) has been shown to have similar efficacy to aripiprazole once every month and was designed to improve medication adherence in order to provide antipsychotic treatment and prevent relapses.

OBJECTIVE

To estimate the financial impact of introducing Ari 2MRTU as a treatment option for adult patients diagnosed with schizophrenia in the United States.

METHODS

A cohort of adult patients with schizophrenia was selected from a hypothetical health plan of 1 million members. Treatment costs were modeled with a 3-year time horizon from 2024 to 2026, in scenarios with or without the addition of Ari 2MRTU. Inputs into the model included estimated current and projected market share of the available antipsychotics, expected uptake of Ari 2MRTU, as well as the acquisition, initiation, and administration costs, hospitalization costs, time on treatment, and patient member medication adherence. The budget impact was estimated as the difference in the annual cost for the total cohort for the current and new scenarios, the cost per member per month and per treated member per month. Deterministic sensitivity analyses were conducted to examine the extent to which the model results were affected by a change in individual all-input parameters.

RESULTS

The total budget impact of Ari 2MRTU being adopted as an alternative maintenance monotherapy for treating eligible patients with schizophrenia from a hypothetical US health plan of 1 million members was estimated to be a saving of $26,998 over 3 years. This represented a per member per month saving of $0.001 and a per treated member per month saving of $0.11, whereas a sensitivity analysis indicated that these savings were sensitive to treatment adherence and the acquisition cost of the new formulation.

CONCLUSIONS

The introduction of Ari 2MRTU as a maintenance treatment for adults with schizophrenia is expected to be cost neutral (with a modest saving) with respect to payer budgets in the United States. This merits consideration as is a potentially favorable option for patients who benefit from less frequent dosing.

摘要

背景

精神分裂症是一种慢性精神疾病,2020年在美国影响了1.1%的成年人口。抗精神病药物治疗常用于精神分裂症的管理,以帮助降低症状复发和病情复发的可能性。阿立哌唑每月一次,是一种长效注射用抗精神病药物制剂,具有既定的疗效和安全性,已获美国食品药品监督管理局批准作为精神分裂症的维持治疗药物。一种新的即用型阿立哌唑制剂,每两个月给药一次(Ari 2MRTU),已显示出与阿立哌唑每月一次具有相似的疗效,其设计目的是提高药物依从性,以便提供抗精神病药物治疗并预防复发。

目的

评估在美国将Ari 2MRTU作为诊断为精神分裂症的成年患者的一种治疗选择所产生的财务影响。

方法

从一个拥有100万成员的假设健康计划中选取一组成年精神分裂症患者。在2024年至2026年的3年时间范围内,对有或没有添加Ari 2MRTU的情况下的治疗成本进行建模。模型的输入包括现有抗精神病药物的估计当前和预计市场份额、Ari 2MRTU的预期采用率,以及获取、起始和给药成本、住院成本、治疗时间和患者成员的药物依从性。预算影响估计为当前和新情景下该队列总年度成本的差异,即每月每位成员和每月每位接受治疗成员的成本。进行确定性敏感性分析,以检查模型结果受单个所有输入参数变化影响的程度。

结果

对于一个拥有100万成员的假设美国健康计划,采用Ari 2MRTU作为治疗符合条件的精神分裂症患者的替代维持单一疗法,估计3年内总预算影响为节省26,998美元。这相当于每月每位成员节省0.001美元,每月每位接受治疗成员节省0.11美元,而敏感性分析表明,这些节省对治疗依从性和新制剂的获取成本敏感。

结论

在美国,引入Ari 2MRTU作为成年精神分裂症患者的维持治疗,预计对支付方预算而言成本中性(有适度节省)。这值得考虑,因为对于受益于给药频率较低的患者来说,这是一个潜在的有利选择。